AstraZeneca/Daisankyo's blockbuster ADC received FDA approval for express second-line treatment of breast cancer

▎WuXi AppTec Content Team Editor Today, the FDA's official website shows that the FDA has approved the expanded indications of Enhertu (trastuzumab deruxtecan), an antibody-drug conjugate (ADC) jointly developed by AstraZeneca and Daiichi Sankyo.
For the treatment of patients with unresectable or metastatic HER2-positive breast cancer who have been previously treated with an anti-HER2-targeted therapy
.

Breast cancer is the most common cancer worldwide, with more than 2 million cases diagnosed in 2020 and nearly 685,000 deaths worldwide
.

About one in five breast cancer cases are considered HER2-positive
.

HER2 is a tyrosine kinase receptor growth-promoting protein that is expressed on the surface of various types of tumors such as breast cancer, gastric cancer, lung cancer, and colorectal cancer.
Overexpression of HER2 protein may be the result of HER2 gene amplification, which is often associated with breast cancer.
The aggressive disease of cancer is associated with poor prognosis
.

Patients with HER2-positive metastatic breast cancer often have disease progression after initial treatment, and more treatment options are needed to further delay disease progression and prolong patient survival
.

Image source: FDA official website Enhertu is an ADC therapy jointly developed by AstraZeneca and Daiichi Sankyo
.

Designed using Daiichi Sankyo's proprietary DXd ADC technology platform, it consists of a humanized monoclonal antibody targeting HER2 linked to a topoisomerase 1 inhibitor payload via a tetrapeptide cleavable linker
.

The approval is based on data from the pivotal Phase 3 clinical trial DESTINY-Breast03
.

In this trial, Enhertu reduced the risk of disease progression or death by 72% in patients with HER2-positive unresectable and/or metastatic breast cancer previously treated with trastuzumab and a taxane compared with the active control group ([ HR]=0.
28; 95% CI: 0.
22-0.
37)
.

Median progression-free survival (PFS) was not reached (95% CI: 18.
5-NE) in patients receiving Enhertu, compared with 6.
8 months (95%) in the active control group, as assessed by a blinded independent central review (BICR) CI: 5.
6-8.
2)
.

There was a clear trend towards improvement in overall survival (OS) with Enhertu (HR=0.
56; 95% CI: 0.
36-0.
86), however, the analysis was not mature enough to reach statistical significance
.

In addition to second-line treatment of patients with HER2-positive breast cancer, Enhertu has been granted Priority Review status by the FDA for a supplemental biologics license application for the treatment of previously treated patients with unresectable or metastatic non-small cell lung cancer (NSCLC) harboring a HER2 mutation
.

It also recently received Breakthrough Therapy Designation from the FDA for the treatment of patients with unresectable or metastatic breast cancer with low HER2 expression
.

It is expected that this blockbuster therapy can benefit more patients
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Reference: [1] Enhertu FDA label.
Retrieved May 4, 2022, from https:// Advances in Medicine and Health Research
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This article is also not a treatment plan recommendation
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For guidance on treatment options, please visit a regular hospital
.